TheraRadar
Data updated: May 26, 2026

ARYMO ER (morphine sulfate)

Trial Activity: Declining 4 active trials
Pain Approved 2017-01-09
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

QRxPharma Inc. conducting 4 trials (14%)
37 indications explored (Broad Platform)
→ pain, postoperative (4 trials)
→ postoperative pain (4 trials)
→ pain (3 trials)
2
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Discontinued
First Approved
2017-01-09
Patent Cliff
2033

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

ZYLA
Active Ingredient: MORPHINE SULFATE

ARYMO ER Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2017 to 2019 · 1 indication expansions
Oct 2019 SUPPL
Label · Labeling
FDA Letter Label
Oct 2018 SUPPL
Efficacy
FDA Letter Label
Sep 2018 SUPPL
Update · REMS
FDA Letter Label

What ARYMO ER Treats

2 FDA approvals

Originally approved for its first indication in 2017 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

29 trials
Trial Sponsor ID Phase Status Title
NCT04429516 PAciFy Cough results posted RBH2019/001 2019-003571-19 Ph 3 completed Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough
NCT05324358 NTM-001-CT001 Ph 3 suspended Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy
NCT04772222 DICE results posted 136561 Ph 2 completed Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
NCT05351229 IRB22-0561 Ph 4 recruiting Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery
NCT04110665 Shoulder1 Local/2017/PC-03 2017-A01316-47 Ph 4 completed Multimodal Analgesia Strategies After Major Shoulder Ambulatory Surgery
NCT05069012 results posted 2021P000688 Ph 4 completed Intrathecal Morphine for Cesarean Delivery
NCT07054775 HE631484 Ph 4 recruiting Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section
NCT03092011 16-144 Ph 4 active not recruiting Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
NCT06160778 KETOAPP 23-0952 Ph 3 recruiting Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
NCT05630222 3401308 Ph 3 completed Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen
NCT05251376 LYN-014-C-101 4UH3DA050310-02 Ph 1 withdrawn Study of LYN-014 in Individuals With Opioid Use Disorder Who Are Stable on Methadone Therapy
NCT03088826 results posted 2017-01-05 Ph 2 completed Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)
NCT04688814 0304884 Ph 3 completed SEQ Block for Perioperative Analgesia in Acetabular Surgery
NCT03483870 Granisetron in C.S Ph 2 completed Effect of Granisetron on Morphine Induced Pruritus in Cesarean Section
NCT04301336 Novel TTT of pedia VOC/SCA Ph 2, Ph 3 completed Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia
NCT03809182 results posted Dexmedetomidine and glycemia. Ph 4 completed Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
NCT02720822 BEAMS 030/15 Ph 3 completed Breathlessness Exertion and Morphine Sulphate
NCT03429400 MORP-OS+T-(2-17)-SPK-2 Ph 3 completed Study of Oral Morphine Sulfate Administration in Pediatric Subjects
NCT02869321 ANTALGIP 2014-003352-32 Ph 4 completed Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy
NCT01708707 Banner IRB 01-13-0030 Ph 2 completed Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
NCT01322360 results posted MORP-OS+T-(2-17)-SPK-1 Ph 4 completed Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
NCT01871285 results posted EN3409-204 Ph 2 completed Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
NCT02455362 022/13 V.3.2.3 Ph 3 withdrawn Opioids for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease
NCT01507220 IMPROVE-Open results posted MA402S23B301 Ph 4 terminated A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301
NCT00901628 results posted B-0804/056-021 Ph 4 completed Periarticular Multimodal Drug Injections in Total Knee Arthroplasty
NCT01016808 Q8003-008 Ph 3 completed Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
NCT00831051 Q8003-021 Ph 2 completed Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
NCT01280331 Q8003-022 Ph 3 completed Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients
NCT00678145 results posted 2012-665 R01DK079974 Ph 2 terminated Mechanisms of Hypoglycemia Associated Autonomic Failure
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ARYMO ER FDA Label Details

View full patent landscape →
2 OB patents · 1 families · 18 international docs across 13 countries

ARYMO ER Patents & Exclusivity

Latest Patent: Jul 2033

Patents (2 active)

US9549899 Expires Jul 1, 2033
US9044402 Expires Jul 1, 2033
Source: FDA Orange Book

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Deep insights for ARYMO ER

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 18 active patents

Trial Analysis

  • • 29 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA208603 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment